Re³ (Re-Cube: Retain Remicade® Response)(Study P04249AM3)

This study has been terminated.
(Study enrollment was stopped due to insufficient subject accrual.)
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00394589
First received: October 31, 2006
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity.

Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion.

A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14.

  • Drug: Infliximab Control (double-blinded)
  • Drug: Infliximab Increased Dose (double-blinded)
  • Drug: Infliximab Increased Frequency (open-label)

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Infliximab Increased Frequency
Drug: Infliximab Increased Dose
Drug: Infliximab Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Disease Activity Score Based on 28 Joint Count (DAS28) Score. [ Time Frame: Between Screening (Week <=1) and Week 24 ] [ Designated as safety issue: No ]
    Descriptive summary of DAS28 (Disease Activity Score Based on 28 Joint Count)change from Baseline to the end of study (Week 24) in the population with available data at both Baseline and Week 24 (increased dose group, n=5; increased frequency group, n=7; and control group, n=5). DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value).


Enrollment: 43
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
Drug: Infliximab Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
Other Name: Increased Frequency
Experimental: Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks
Drug: Infliximab Increased Dose
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks
Other Name: Increased Dose
Active Comparator: Control
Continuation of infliximab 3 mg/kg every 8 weeks
Drug: Infliximab Control
Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks
Other Name: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18 years or more
  • with RA according to ACR criteria
  • presented with a disease flare after initial response to infliximab, with both response and flare being defined using the DAS28 score (EULAR criteria)
  • received the standard Remicade® dosing schedule per the EU label (3 mg/kg at Weeks 0, 2, 6, [and 14])
  • an initial response documented by moderate or good DAS28 improvement (EULAR criteria) from Week 0 to Week 6 or 14.

Exclusion Criteria:

  • a female who is, or intends to become, pregnant during or within 6 months of the end of the study, is nursing or not using adequate contraceptive measures
  • has not observed the designated periods for concomitant medications
  • used any investigational medical product within 30 days prior to Baseline
  • any clinically significant deviation from normal in the physical examination or chest X-ray that in the investigator's judgment, may interfere with the study evaluation or affect subject safety
  • rheumatic disease other than RA or has any systemic inflammatory condition with signs and symptoms that might confound the evaluations of safety and toxicity
  • allergic reaction/sensitivity to the study drug or its excipients that requires corticosteroid pre-infusion medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00394589     History of Changes
Other Study ID Numbers: P04249
Study First Received: October 31, 2006
Results First Received: October 28, 2009
Last Updated: April 30, 2014
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Ministry of Social Affairs, Public Health and the Environment
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Paul-Ehrlich-Institut
Greece: Ministry of Health and Welfare
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Sweden: Medical Products Agency
Turkey: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014